FDA rules it will only be available when other medications don't work for patients

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European regulators ordered the diabetes drug Avandia off the market and the U.S. Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the former blockbuster are too great a safety concern to continue its use for most people.

In simultaneous news briefings Thursday, the European Medicines Agency and the U.S. Food and Drug Administration announced their long-awaited decisions on the fate of GlaxoSmithKline's controversial drug. The European regulator said it would stop authorizing marketing of Avandia, which will be off the market within the next few months.

The FDA said new patients will be able to get a prescription for Avandia, but only if they can't control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks. FDA expects the restricted plan "will limit use of Avandia significantly."

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

"Although the European Medicines Agency went further by actually suspended marketing of the drug, both regulatory decisions result in essentially the same outcome, virtually complete elimination of the use of this drug by patients around the world," said Dr. Steve Nissen of the Cleveland Clinic. Nissen, who published the first paper linking Avandia to heart risks, said only a small number of U.S. patients would receive the drug under the new restrictions.

GlaxoSmithKline's chief medical officer, Dr. Ellen Strahlman, said in a statement that the company will voluntarily stop promoting Avandia in all countries where it operates.

"The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions."

The safety of Avandia, the brand name for rosiglitazone, has been the top drug safety controversy facing the FDA, and its split from European regulators is sure to draw criticism from public safety advocates and confuse patients.

The FDA's top drug reviewer said the evidence against Avandia was not strong enough to warrant withdrawal.

"As a matter of prudence we are restricting access," said the FDA's Dr. Janet Woodcock. "We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether or not it is valid."

The decision marks the second time in three years that the agency has decided to leave Avandia on the market, despite mounting pressure from outside medical experts, politicians and some of its own scientists.

The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world. But use has plummeted since a 2007 analysis linked the drug to heart attack risks.

The European Commission still must approve the recommendations by the European Medicines Agency, a process that could take several weeks. Decisions by the health regulators usually are not challenged.

"In light of all the information available and including results from some very recent studies, the committee concluded that as of today, the benefits of rosiglitazone can no longer be considered to outweigh its risks," Dr. Hans-Georg Eichler, EMA's senior medical officer, said Thursday.

"Rosiglitazone was authorized more than 10 years ago," he said. "Even at that time, there was a question mark over rosiglitazone's cardiovascular safety.

"What you're hearing today is the latest step in a chain of regulatory assessments and actions," Eichler said.

Eichler said the EMA and the FDA communicated frequently and shared data and other information in reviewing the drug's safety, and said that, in the end, both agencies reached similar conclusions.

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

"We're operating in different health care environments, we have different legal frameworks and we had different starting points," he said in explaining the contrast in action taken by the agencies. "In Europe, we already had a very restricted indication for this drug so we both concluded that in the context of our environments, these are the best ways forward."

FDA's critics have framed the Avandia decision as a key test of the agency's Obama-appointed leadership, who vowed to bolster the agency's regulatory stance after a series of drug safety problems under the previous administration.

FDA Commissioner Margaret Hamburg said the FDA's decision reflects its unique powers to restrict access to medications. While pulling a drug off the market is an extremely rare event in the U.S., it is more common in Europe, where drugs are approved on a conditional basis.

"We are taking somewhat different strategies, but both strategies are designed to assure the goals of safety and effectiveness," Hamburg said in a briefing with reporters.

The FDA's decision on Avandia is likely to draw ire from safety advocates and U.S. lawmakers, though it essentially concurs with the opinion outside experts reached earlier this year.

In July, a 33-member panel of medical experts voted 20-12 to keep Avandia available in the U.S. Of the 20 who voted to keep it on the market, 10 said it should only be available on a limited basis. The FDA is not required to follow the group's advice, though it often does.

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